Qc Executive

**Position**: QC/QA Executive

**Location**:Nagpur, Maharashtra Office

**Timings**: 10 am to 7 pm (Full time)

(DO NOT APPLY IF YOU ARE NOT FROM NAGPUR OR DO NOT WISH TO RELOCATE TO NAGPUR)

**Experience Required**:At least 3 - 4 years

**Educational Qualifications**: Bachelor’s/Master’s degree

**Key Responsibilities**:
1. Quality Management System (QMS) Maintenance: o Ensure the effective implementation and maintenance of the company’s Quality Management System in compliance with regulatory standards (e.g., ISO, GMP). o Oversee the documentation related to QMS, including batch release, change control, deviation reports, and corrective actions. o Collaborate with cross-functional teams to ensure that QMS documentation is up-to-date and aligned with production processes.

2. Batch Release and Documentation: o Manage batch release activities, ensuring that all products meet the required quality standards before they are released for distribution. o Review and approve production batch records, ensuring they are complete and accurate. o Conduct artwork proofing and label control to ensure consistency with product specifications and regulatory requirements.

3. FDA Portal XLN Exposure: o Handle submissions and documentation related to product registration and regulatory compliance through the FDA XLN portal. o Ensure that all required documentation for product registration, manufacturing, and batch release is submitted accurately and on time.

4. Analytical Testing for Quality Control (QC): o Perform routine and advanced analytical testing of raw materials, in process materials, and finished products to verify quality and compliance. o Develop and validate analytical methods as required and maintain detailed documentation of all QC testing and results. o Investigate and resolve any non-conformances or deviations in product quality, reporting findings to management.

5. Labeling and Artwork Control: o Ensure all product labels, packaging, and artwork are compliant with regulatory guidelines and company standards. o Review and approve labels, packaging artwork, and related documents to verify accuracy in product information, ingredient listings, and compliance with regulatory norms.

6. Regulatory Compliance:

- Ensure that all products and processes meet relevant industry regulations, including those from local and international regulatory bodies.
- Stay updated on regulatory changes and implement necessary updates to the QMS and other quality-related documents.

7. Continuous Improvement and Audits: o Participate in internal and external quality audits and ensure prompt resolution of audit findings. o Lead initiatives to continuously improve quality processes and systems to enhance product quality and regulatory compliance.

8. Reporting and Documentation:

- Maintain accurate and detailed records of all quality control and assurance activities, including analytical test results, batch records, and regulatory documentation.
- Generate regular reports for management on quality performance, trends, and areas requiring attention.

**Qualifications and Skills**:

- Education: B.Tech or M.Tech in Cosmetics, or B.Pharma from a recognized institution.
- Experience: 3 to 4 years of experience in Quality Control/Quality Assurance within the cosmetics, pharmaceutical, or related industries.
- Knowledge and Skills: o Strong understanding of Quality Management Systems (QMS) and relevant regulatory requirements (e.g., GMP, ISO).
- Familiarity with FDA portal XLN for regulatory submissions.
- Analytical experience in QC testing, including method development and validation.
- Experience with batch release, artwork proofing, and label control. o Excellent documentation skills with attention to detail in preparing regulatory and quality documents.
- Ability to work independently and manage multiple tasks efficiently.

**Work Environment**: - Laboratory and office-based work with close collaboration with cross functional teams, including production, regulatory affairs, and R&D.

**Job Types**: Full-time, Permanent

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

Application Deadline: 10/09/2024